Safety Events For Accelerated Approval Drugs Highlighted As Expansion Looms
US drugs with accelerated approval are more likely to experience a postmarket safety event, JAMA study finds; data sharing could be a solution to filling information gaps.
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Pivotal Studies Supporting US FDA Drug Approvals Have Declined, JAMA Research Finds
Over 30-year period, approvals increasingly used expedited programs and were based on fewer pivotal trials with less robust comparators, authors report.
US FDA Pushes Back Against Critics: Breakthrough Is Not A Drug 'Beauty Contest'
Richard Pazdur, FDA's oncology chief, reiterates the breakthrough therapy designation is for agency-sponsor communication and not an investor tool.
External Collaboration At US FDA Is More Difficult Than At NIH, Sharpless Says
Acting US FDA commissioner Norman Sharpless outlines some key differences between his new position and his former role at the NCI.